CAMERA READY CC BROAD SPECTRUM SPF 30- octinoxate, octisalate, oxybenzone, and titanium dioxide cream

CAMERA READY by

Drug Labeling and Warnings

CAMERA READY by is a Otc medication manufactured, distributed, or labeled by SMASHBOX BEAUTY COSMETICS, INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 7.50%
Octisalate 4.00%
Oxybenzone 2.50%
Titanium Dioxide 1.10%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive Ingredients

Water\Aqua\Eau, Dimethicone, Butylene Glycol, Propanediol, Glyceryl Stearate, Phenyl Trimethicone, Behenyl Alcohol, Trioctyldodecyl Citrate, Polymethylsilsesquioxane, Ascorbyl Glucoside, PEG-40 Stearate, Polyglyceryl-10 Pentastearate, Octyldodecyl Stearoyl Stearate, Hordeum Vulgare (Barley) Extract\Extrait D'Orge, Triticum Vulgare (Wheat) Germ Extract, Glycyrrhiza, Glabra (Licorice) Root Extract, Pyrus Malus (Apple) Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Octyldodecyl Neopentanoate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polyglyceryl-6 Polyricinoleate, Laminaria Saccharina Extract, Glycyrrhetinic Acid, Sucrose, Scutellaria Baicalensis Root Extract, Lecithin, Sodium Stearoyl Lactylate, Caffeine, Acetyl Hexapeptide-8, Cholesterol, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopheryl Linoleate/Oleate, Linoleic Acid, Dimethoxytolyl Propylresorcinol, Squalane, Sodium PCA, Urea, Bisabolol, Isopropyl Titanium Triisostearate, Glycerin, Oryzanol, Sodium Hyaluronate, Trehalose, Polyquaternium-51, Stearic Acid, Silica, Ergothioneine, Xanthan Gum, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Alumina, Disodium EDTA, Phenoxyethanol, Sodium Dehydroacetate, Chlorphenesin, [+/- Iron Oxides (CI 77492), Zinc Oxide (CI 77497), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77499)] <ILN39783>

Other information

• protect the product in this container from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

Smashbox Cosmetics, Dist.
Culver City, CA 90232

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

smashbox
camera
ready

CC
CREAM
BROAD SPECTRUM
SPF 30

DARK SPOT
CORRECTING

BROAD SPECTRUM SPF 30
1 fl. oz. / 30 ml e

INGREDIENTS AND APPEARANCE

CAMERA READY   CC BROAD SPECTRUM SPF 30
octinoxate, octisalate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10348-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.08175 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0436 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02725 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0119 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)
Butylene Glycol (UNII: 3XUS85K0RA)
Propanediol (UNII: 5965N8W85T)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Docosanol (UNII: 9G1OE216XY)
Trioctyldodecyl Citrate (UNII: 35X8CT063R)
Ascorbyl Glucoside (UNII: 2V52R0NHXW)
PEG-40 Stearate (UNII: ECU18C66Q7)
Octyldodecyl Stearoyl Stearate (UNII: 3D47Q6D93C)
Wheat Germ (UNII: YR3G369F5A)
Glycyrrhiza Glabra (UNII: 2788Z9758H)
Apple (UNII: B423VGH5S9)
Cucumber (UNII: YY7C30VXJT)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)
Saccharina Latissima (UNII: 68CMP2MB55)
Enoxolone (UNII: P540XA09DR)
Sucrose (UNII: C151H8M554)
Scutellaria Baicalensis Root (UNII: 7J95K7ID2S)
Sodium Stearoyl Lactylate (UNII: IN99IT31LN)
Caffeine (UNII: 3G6A5W338E)
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)
Cholesterol (UNII: 97C5T2UQ7J)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Linoleic Acid (UNII: 9KJL21T0QJ)
Squalane (UNII: GW89575KF9)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Urea (UNII: 8W8T17847W)
Levomenol (UNII: 24WE03BX2T)
Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)
Glycerin (UNII: PDC6A3C0OX)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Trehalose (UNII: B8WCK70T7I)
Stearic Acid (UNII: 4ELV7Z65AP)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Ergothioneine (UNII: BDZ3DQM98W)
Xanthan Gum (UNII: TTV12P4NEE)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
Aluminum Oxide (UNII: LMI26O6933)
Edetate Disodium (UNII: 7FLD91C86K)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Dehydroacetate (UNII: 8W46YN971G)
Chlorphenesin (UNII: I670DAL4SZ)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Zinc Oxide (UNII: SOI2LOH54Z)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferrosoferric Oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10348-014-01	1 in 1 CARTON	02/01/2013
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2013

Labeler - SMASHBOX BEAUTY COSMETICS, INC (945344414)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(10348-014) , REPACK(10348-014)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(10348-014)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(10348-014)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(10348-014)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(10348-014)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(10348-014) , REPACK(10348-014)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(10348-014) , REPACK(10348-014)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(10348-014)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(10348-014)